OncoMatch/Clinical Trials/NCT06815003
Vedolizumab Plus Post-transplant Cyclophosphamide and Short Course Tacrolimus for the Prevention of Graft Versus Host Disease in Patients Undergoing Allogeneic Hematopoietic Cell Transplantation After Reduced Intensity Conditioning
Is NCT06815003 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for acute lymphoblastic leukemia.
Treatment: Cyclophosphamide · Fludarabine · Melphalan · Tacrolimus · Vedolizumab — This phase II trial studies how well vedolizumab plus post-transplant cyclophosphamide (PTCy) and short course tacrolimus work for the prevention of graft versus host disease (GVHD) in patients undergoing allogeneic hematopoietic cell transplantation (HCT) after reduced intensity conditioning. Allogeneic HCT is a procedure in which a person receives blood-forming stem cells (cells from which all blood cells develop) from a donor. Giving reduced conditioning chemotherapy before an allogeneic HCT helps kill cancer cells in the body and helps make room in the patient's bone marrow for new stem cells to grow using less than standard doses of chemotherapy. Sometimes, the transplanted cells from a donor can attack the body's normal cells (called graft-versus-host disease). Vedolizumab is a monoclonal antibody, which is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). It may reduce inflammation. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid and may kill cancer cells. It may also lower the body's immune response. Tacrolimus suppresses the immune system by preventing the activation of certain types of immune cells. Giving vedolizumab plus PTCy and short course tacrolimus may be effective at preventing GVHD after allogeneic HCT.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Lymphoblastic Leukemia
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Myeloproliferative Neoplasm
Prior therapy
Cannot have received: allogeneic hematopoietic cell transplantation
Prior allogeneic HCT
Cannot have received: chemotherapy
Exception: conditioning regimen within 14 days prior to day 1 of protocol therapy is not considered as an exclusion criterion; patients on maintenance chemotherapy with agents listed are not excluded
Chemotherapy, radiation therapy, biological therapy, immunotherapy within 14 days prior to day 1 of protocol therapy
Cannot have received: radiation therapy
Exception: conditioning regimen within 14 days prior to day 1 of protocol therapy is not considered as an exclusion criterion; patients on maintenance chemotherapy with agents listed are not excluded
Chemotherapy, radiation therapy, biological therapy, immunotherapy within 14 days prior to day 1 of protocol therapy
Cannot have received: biological therapy
Exception: conditioning regimen within 14 days prior to day 1 of protocol therapy is not considered as an exclusion criterion; patients on maintenance chemotherapy with agents listed are not excluded
Chemotherapy, radiation therapy, biological therapy, immunotherapy within 14 days prior to day 1 of protocol therapy
Cannot have received: immunotherapy
Exception: conditioning regimen within 14 days prior to day 1 of protocol therapy is not considered as an exclusion criterion; patients on maintenance chemotherapy with agents listed are not excluded
Chemotherapy, radiation therapy, biological therapy, immunotherapy within 14 days prior to day 1 of protocol therapy
Cannot have received: investigational drug for GVHD prophylaxis
Other investigational drugs for GVHD prophylaxis
Lab requirements
Blood counts
Hemoglobin ≥ 9g/dL (no RBC transfusion within 14 days unless cytopenia is secondary to disease involvement)
Kidney function
Creatinine clearance of ≤ 1.5 mg/dL or ≥ 60 mL/min per 24 hour urine test or Cockcroft-Gault formula
Liver function
Total bilirubin ≤ 2.0 mg/dL (unless has Gilbert's disease) AND SGOT and SGPT < 5x ULN; AST ≤ 3.0 x ULN; ALT ≤ 3.0 x ULN
Cardiac function
Left ventricular ejection fraction (LVEF) ≥ 50%
Hemoglobin ≥ 9g/dL (within 30 days prior to day 1 of protocol therapy) Total bilirubin ≤ 2.0 mg/dL (unless has Gilbert's disease) AND SGOT and SGPT < 5x ULN (within 30 days prior to day 1 of protocol therapy) AST ≤ 3.0 x ULN (within 30 days prior to day 1 of protocol therapy) ALT ≤ 3.0 x ULN (within 30 days prior to day 1 of protocol therapy) Creatinine clearance of ≤ 1.5 mg/dL or ≥ 60 mL/min per 24 hour urine test or Cockcroft-Gault formula (within 30 days prior to day 1 of protocol therapy) Left ventricular ejection fraction (LVEF) ≥ 50%
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- City of Hope Medical Center · Duarte, California
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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